Basic ISO 9001 2015
Quality Management
System - Awareness
July. 27.2024
Training Objectives
• An understanding of ISO
9001:2015 requirements &
interpretation of the ISO clauses.
• An understanding of the
requirements and application of
Quality Management System
(QMS)
• An Understanding on Risk Based
Approach
Training
Contents
• Overview of ISO 9001
• Introduction to QMS &
Requirements
• Interpretation of the ISO
9001:2015 clauses
• Non-governmental organization (NGO) established in 1947,
About ISO based in Geneva, Switzerland
• Has a membership of 163 national standards institutes
from countries in all regions of the world
• Developed various standards for all dimensions of sustainable
development: economic, environmental and societal.
• Examples :
➢ ISO 9001 – Quality Management Systems (QMS)
About ISO ➢ ISO 14001 – Environmental Management Systems (EMS)
➢ ISO 27001 – Information Security Management Systems (ISMS)
➢ ISO 31000 – Risk Management (Principles and Guidelines)
What is ISO
9001?
• ISO 9001 is the world’s most
popular and most commonly
used standard for Quality
Management Systems (QMS)
• International consensus on good
management practice
• Focuses on meeting customer
requirements and other
interested parties
• Covers any organization –
whatever the size, industry or
culture
Benefits of the New ISO
9001:2015
Puts greater emphasis on leadership engagement
Helps address organizational risks and
opportunities in a structured manner
Uses simplified language and a common structure
and terms
Addresses supply chain management more
effectively
Is more user-friendly for service and knowledge-
based organizations
Advantages of
Certification
• Compliance with customer
requirements specifying
certification
• Independent check of conformity
• Indicates an effective Quality
System
• National/International recognition
• Provides competitive advantage
• Improves company image
RISK BASED
MANAGEMENT
• To assure consistency of quality of
products and services
• Successful companies take a risk
based approach.
• Prevent or reduce undesired effects.
ISO 9001
Approach is
Based on the
Plan-Do-
Check-Act
(PDCA) Cycle
QUALITY MANAGEMENT PRINCIPLE
CUSTOMER ENGAGEMENT PROCESS
LEADERSHIP
FOCUS OF PEOPLE APPROACH
EVIDENCE
RELATIONSHIP
IMPROVEMENT BASED DECISION
MANAGEMENT
MAKING
CLAUSES OF ISO 9001:2015
PDCA and ISO 9001 Clause
Structure
ISO 9001 Clause Structure (4-10)
Representation of the structure of this
International Standard in the PDCA cycle
4. CONTEXT OF • 4.1 Understanding the organization and its context
• 4.2 Understanding the needs and expectations of interested
THE parties
• 4.3 Determining the scope of the quality management
ORGANIZATION
system (QMS)
• 4.4 Quality management system and its processes
5.
LEADERSHIP
5.1 Leadership and
commitment
5.2 Quality Policy
5.3 Organizational roles,
responsibilities and authorities
6. PLANNING
• 6.1 Actions to address risks and
opportunities
• 6.2 Quality objectives and planning
to achieve them
• 6.3 Planning of changes
7. SUPPORT
• 7.1 Resources
• 7.2 Competence
• 7.3 Awareness
• 7.4 Communication
• 7.5 Documented
Information
8. OPERATION
• 8.1 Operational planning and control
• 8.2 Requirement for products &
services
• 8.3 Design and development of
product and services
• 8.4 Control of externally provided
processes, products and services
• 8.5 Production and service provision
• 8.6 Release of products and services
• 8.7 Control of nonconforming outputs
• 9.1 Monitoring, measurement, analysis and evaluation
9. PERFORMANCE • 9.2 Internal Audit
EVALUATION • 9.3 Management review
10. • 10.1 General
• 10.2 Nonconformity and corrective action
IMPROVEMENT • 10.3 Continual Improvement
Questions
THANK
YOU
